Another day, another xenotransplant, as United Therapeutics looks to beat competitors to sci-fi-esque breakthrough
Xenotransplantation is having a moment.
Last October, a team from NYU successfully transplanted a kidney from a pig into a brain-dead patient, although observers cast doubt on the importance of the experiment. Then, earlier this month, surgeons at the University of Maryland transplanted a pig heart into a dying human, who appears to still be stable.
Now, another group is planting a flag in the xenotransplantation field. Surgeons at the University of Alabama at Birmingham said Thursday they have achieved the first kidney transplant from a pig to a brain-dead patient, publishing their peer-reviewed findings online. The team, aiming to differentiate itself from the others through the genetic modifications used, is hoping there’s now enough research to soon begin clinical xenotransplantation studies.
“We have bridged critical knowledge gaps and obtained the safety and feasibility data necessary to begin a clinical trial in living humans with end-stage kidney failure disease,” said Jayme Locke, director of the UAB surgery department’s transplantation institute, in prepared remarks.
The common thread through all these transplantation efforts? That would be United Therapeutics’ Revivicor, which supplied the organs to each of the academic teams in question. The biotech’s genetically altered pigs were approved by the FDA in December 2020 for use in food and potential therapeutic uses.
Each of the Revivicor organs used contained genetic modifications, but the NYU procedure only included the elimination of a certain sugar from the organ’s surface, with the goal of reducing the body’s rejection response. The Maryland and UAB teams, meanwhile, used organs containing at least 10 different genetic modifications.
Like the Maryland team, UAB researchers transplanted the organ inside the patient’s body, whereas NYU only sutured the kidney to the patient’s leg. UAB, though, conducted its procedure on a brain-dead patient as NYU did, while Maryland transplanted the pig heart into a terminally ill man.
Given the massive shortage of available organs for patients who need transplants, scientists have for years theorized how to safely and effectively make xenotransplantation work. In addition to Revivicor, biopharmas such as Tector, eGenesis and Qihan Biotech are working to develop ready-made organs.
In particular, eGenesis proved the early VC favorite, winning backing from prominent firms like Bayer’s investment arm and Farallon, in addition to Harvard. But the company is still waiting to hold a pre-IND meeting with the FDA, eGenesis spokesperson David Carmel told Endpoints News. And though eGenesis has acquired the necessary pathogen-free facility that Carmel said meets all FDA criteria, regulators have yet to inspect it and likely won’t do so until the company is ready to make a product that can be put into humans.
Kidneys in particular could be a potential gold mine for companies able to breed genetically modified pigs and a relief for patients and their families. More than 800,000 Americans are living with kidney failure and most never receive a donor’s kidney. That can result in intensive and excruciating dialysis treatments, sharply reducing patients’ quality of life.
Update: This article has been updated with comment from eGenesis.